An interventional study of Ibuprofen administration in Sepsis, Severe Sepsis and Septic Shock, sponsored by University Hospital Ostrava. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-14.
Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Treatment
The benefits of fever treatment in critically ill patients remains unclear. The aim of the prospective, randomized clinical trial was to verify the hypothesis that the administration of ibuprofen in order to decrease the fever in septic patients without limited cardiorespiratory reserve leads to decreasing their prognosis.
Fever is a frequently observed part of the organism's response to infection, and it is a well-known fact that it has positive effects, as it inhibits the growth of microorganisms, and potentiates the activity of anti-microbial agents. On the other hand, fever increases the demand of tissues for oxygen and increases the production of carbon dioxide in tissues. Adapting to these metabolic changes requires an efficient cardiorespiratory apparatus. In other words, in patients with a limited cardiorespiratory reserve (typically patients of higher age or patients with a serious disease of the heart or lungs), the beneficial anti-microbial effect of fever may be masked with cardiorespiratory maladaptation to fever-induced metabolic changes. Indeed, one of the randomized clinical trials investigating the effect of "aggressive" antipyretic strategy used in practice (administration of acetaminophen at the temperature > 38.5 degrees Celsius, and addition of physical cooling should the temperature exceed 39.5 degrees Celsius upon the prognosis of critically ill patients showed that the "aggressive" treatment of fever may result in higher mortality when compared with a "permissive" approach, i.e. an approach when the treatment of fever is initiated only after the body temperature has exceeded 40 degrees Celsius. The study differs remarkably from other studies performed among the population of critically ill patients, and also from studies, which did not manifest the effect of fever treatment upon the mortality of patients, with the age of patients. The average age of patients in both arms of the study was only 47 years of age, whereas the average age of patients in other studies was usually around 60 years of age. It is thus possible to presume that, due to the lower age, the patients in this study possessed a sufficient cardiorespiratory reserve for adaptation to metabolic changes induced with fever, which may have enabled a full manifestation of its anti-microbial effect, and may have led to better patient prognosis. The mortality rate in the group of patients with the "permissive" approach to fever treatment was only 2.6 percent, whereas, in the group of patients with the "aggressive" treatment, the mortality rate was 15.9 percent (p=0.06); due to this fact, the study was prematurely terminated by the Ethics Committee. Based on this study, we decided to test the hypothesis that the administration of ibuprofen in order to decrease the fever would lead to a worsening of the patient prognosis. Ibuprofen was selected due to its potent antipyretic effect, and also due to the fact that the favorable effect of its anti-inflammatory effect upon the prognosis of patients with sepsis has not been fully demonstrated.
1,894 studies on the registry are indexed under Sepsis; 458 are open to participants now.
This study's enrollment of 140 is above the median of 105 across 893 interventional studies indexed under Sepsis.
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The antipyretic strategy was initiated immediately upon increase of the temperature above 38.3°C. The antipyretic strategy consisted of administration of ibuprofen (per-orally or into the nasogastric tube, or rectal administration in the form of a suppository) in therapeutical dose, alway supplemented with physical cooling in cases when the temperature exceeded 39.5°C. The body temperature was measured in the urinary bladder.
Drug: Ibuprofen administration
The antipyretic strategy was initiated only after the body temperature exceeded 39.5°C. The antipyretic strategy consisted of administration of ibuprofen (per-orally or into the nasogastric tube, or rectal administration in the form of a suppository) in therapeutical dose, alway supplemented with physical cooling in cases when the temperature exceeded 39.5°C. The body temperature was measured in the urinary bladder.
Drug: Ibuprofen administration
Administration of ibuprofen, according to treatment recommendations - per orally, into the nasogastric tube, or in the form of a suppository
SOFA score value
The SOFA score (Sequential Organ Failure Assessment) was measured on Day 3 and Day 7
Time frame: up to 7 days
Serum interleukin-6 level
The serum interleukin-6 level was measured on Day 3 and Day 7
Time frame: up to 7 days
Serum procalcitonine level
The serum procalcitonine level was measured on Day 3 and Day 7
Time frame: up to 7 days
Serum lactate level
The serum lactate level was measured on Day 3 and Day 7
Time frame: up to 7 days
Central venous oxygen saturation
The central venous oxygen saturation was measured on Day 3 and Day 7
Time frame: up to 7 days
Duration of artificial ventilation
The duration of artificial ventilation in days was observed
Time frame: 1 month
Duration of vasopressor support
The duration of vasopressor support in days was observed
Time frame: 1 month
Length of ICU stay
The length of ICU stay in days was observed
Time frame: 1 month
Length of hospital stay
The length of hospital stay in days was observed
Time frame: 3 months
Plan to share: No — There exists no plan to make individual participant data available to other researchers.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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University Hospital Ostrava